Senior Regulatory Business Analyst
Core
Establish and implement Software as a Medical Device (SaMD) regulatory frameworks to ensure digital health products and AI solutions comply with medical device regulations.
Role type
Senior Regulatory Business Analyst (SaMD)
Builds
Regulatory management frameworks, governance processes, and compliance controls for digital health products.
Domain
Healthcare / Digital Health / Medical Device Regulation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SaMD regulatory framework development, regulatory gap assessment, requirements traceability, stakeholder engagement, process mapping, regulatory risk assessment, audit support, post-market surveillance, regulatory reporting, TGA requirements interpretation, business analysis
Preferred skills
TGA submission preparation, ISO 13485, ISO 14971, IEC 62304 training
Technologies
None explicitly listed beyond regulatory standards
Responsibilities
Lead development of SaMD regulatory management framework, interpret medical device regulations into operational requirements, assess software products against regulatory frameworks, establish regulatory controls and documentation processes, support audits and inspections, embed regulatory requirements in software lifecycle, review digital health initiatives for regulatory impact.
Seniority
Senior, hands-on IC
